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临床试验/NCT07139847
NCT07139847尚未招募不适用

Effect of Intraoperative Magnesium Infusion on Postoperative Emergence Agitation in Patients Undergoing Lumbar Microdiscectomy

Ondokuz Mayıs University0 个研究点目标入组 70 人开始时间: 2026年7月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
主要终点
Incidence of Emergence Agitation in the PACU

研究概览

简要总结

In this retrospective study, the effect of intraoperative magnesium sulfate infusion on the incidence of postoperative emergence agitation was evaluated in adult patients who underwent elective lumbar microdiscectomy under general anesthesia. The medical records of patients aged 18-70 years with an ASA physical status of I-II were retrospectively reviewed. Patients were evaluated according to whether they received intraoperative magnesium sulfate infusion as part of anesthetic management. The primary outcome measure was the incidence of emergence agitation in the post-anesthesia care unit; this assessment was based on Ramsay Sedation Scale scores recorded in the post-anesthesia care unit at admission and at 5, 10, 15, and 30 minutes. Secondary outcome measures included postoperative pain scores assessed using the Numeric Rating Scale, intraoperative remifentanil consumption, recovery and extubation times, tramadol requirement in the post-anesthesia care unit, and possible adverse events related to magnesium infusion.

详细描述

This retrospective study was conducted at Giresun Training and Research Hospital. The aim of the study was to evaluate the effect of intraoperative magnesium sulfate infusion on postoperative emergence agitation in patients undergoing elective lumbar microdiscectomy under general anesthesia.

After institutional ethics committee approval was obtained, the medical records of adult patients aged 18-70 years, classified as ASA physical status I or II, who underwent single-level elective lumbar microdiscectomy under general anesthesia were retrospectively reviewed.

Patients were evaluated in two groups according to intraoperative anesthetic management:

Magnesium Group (Group M): Patients who received a 30 mg/kg intravenous bolus of magnesium sulfate over 15 minutes after induction, followed by a continuous magnesium sulfate infusion at a dose of 10 mg/kg/h until the end of surgery.

Control Group (Group K): Patients who did not receive magnesium sulfate infusion and were managed with a standard anesthesia protocol.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

盲法说明

Both participants and clinical staff (including anesthesia providers) were blinded to group allocation. Group assignments were determined using sealed opaque envelopes and were only known to an anesthesia technician not involved in patient care or outcome assessment. The infusion solutions (magnesium sulfate or 0.9% saline) were prepared in identical syringes to maintain blinding.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 70 years
  • ASA physical status classification I or II
  • Scheduled for elective single-level lumbar microdiscectomy under general anesthesia
  • Ability to provide written informed consent

排除标准

  • Severe cardiovascular disease
  • History of psychiatric disorder
  • Neuromuscular disease
  • Pregnancy or breastfeeding
  • Hepatic or renal dysfunction
  • Current use of calcium channel blockers, hypnotics, anxiolytics, or antipsychotic medications
  • Known allergy to magnesium sulfate or study-related medications
  • Refusal to participate in the study

研究组 & 干预措施

Magnesium Sulfate Infusion

Patients who underwent elective single-level lumbar microdiscectomy under general anesthesia and received intraoperative magnesium sulfate infusion as part of anesthetic management were included in this group. Magnesium sulfate was administered as a 30 mg/kg intravenous bolus over 15 minutes after induction, followed by a continuous infusion at 10 mg/kg/h until the end of surgery.Intraoperative magnesium sulfate infusion was retrospectively evaluated. Magnesium sulfate had been administered as part of routine anesthetic management and was not an intervention assigned by the investigators for the purpose of this retrospective study.

干预措施: Magnesium Sulfate Infusion (Drug)

0.9% Saline Infusion

Patients who underwent elective single-level lumbar microdiscectomy under general anesthesia and did not receive intraoperative magnesium sulfate infusion were included in this group. These patients were managed with the standard anesthesia protocol.Patients in this group had not received intraoperative magnesium sulfate infusion. Standard anesthetic management was retrospectively evaluated from medical records and was not an intervention assigned by the investigators for the purpose of this retrospective study.

干预措施: 0.9% Saline Infusion (Drug)

结局指标

主要结局

Incidence of Emergence Agitation in the PACU

时间窗: At PACU admission (T0) and at 5, 10, 15, and 30 minutes post-admission.

Percentage of participants with a Ramsay Sedation Scale (RSS) score ≥5, indicating emergence agitation, in the post-anesthesia care unit (PACU)

次要结局

  • Postoperative Pain Scores in PACU(At PACU admission (T0) and at 5, 10, 15, and 30 minutes post-admission.)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilke Tamdogan

M.D.

Ondokuz Mayıs University

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